Dialysis catheter set and method of using same

ABSTRACT

A catheter set and method of use is provided. The set includes an insert, which fills the majority of the inside annular space within the catheter. Only a small space is left between the catheter and the insert, which is filled with a heparinized saline. The insert and saline prevent fibrin, proteins and other material from collecting inside the catheter, which is especially helpful in the Stepwise Moncrief and Popovich (“SMAP”) catheter insertion, where the catheter is left inside the patient for one to six months before PD therapy begins.

BACKGROUND OF THE INVENTION

The present invention relates generally to medical treatments. Morespecifically, the present invention relates to a catheter and method ofusing same in medical treatments, such as Peritoneal Dialysis (“PD”).

Due to disease or other causes, a person's renal system can fail. Inrenal failure of any cause, there are several physiologicalderangements. The balance of water, minerals and the excretion of dailymetabolic load is no longer possible in renal failure. During renalfailure, toxic end products of nitrogen metabolism (urea, creatinine,uric acid, and others) can accumulate in blood and tissues.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving. One who has failedkidneys could not continue to live without replacing at least thefiltration functions of the kidneys.

PD uses a dialysis solution or dialysate, which is infused into apatient's peritoneal cavity. The dialysate contacts the patient'speritoneal membrane in the peritoneal cavity. Waste, toxins, and excesswater pass from the patient's bloodstream through the peritonealmembrane and into the dialysate. The transfer of waste, toxins, andwater from the bloodstream into the dialysate occurs by diffusion andosmosis because there is an osmotic gradient across the peritonealmembrane. The spent dialysate is drained from the patient's peritonealcavity to remove the waste, toxins and water from the patient. Newdialysate replaces the spent dialysate and the process is repeated.

During dialysis therapy, a dialysis fluid exchange generally includesdraining spent dialysis fluid from the peritoneal cavity and filling theperitoneal cavity with fresh dialysate. Dialysis fluid exchanges havebeen performed manually (Continuous Ambulatory Peritoneal Dialysis or“CAPD”), usually by the patient, or automatically (Automated PeritonealDialysis technique or “APD”), by an automated dialysis machine.

Both the manual and automated PD techniques require insertion of acatheter into the peritoneal cavity of the patient. A dialysis solution(“dialysate”) is introduced through the catheter into the peritonealcavity of a patient. The dialysate remains in the peritoneal cavity forseveral hours. Thereafter, the dialysate is removed from the peritonealcavity carrying with it diffused breakdown products from the blood. Thespent dialysate container is disconnected and discarded, wherein a newcontainer of dialysate fluid is attached and the process is repeated.The process is repeated typically several times. The catheterimplantation, however, is semi-permanent and a single catheter is usedfor many PD exchanges.

The installation of the PD catheter can have complications, whichdespite improvements in catheter implementations over the last fewyears, can still lead to the removal of the catheter. Catheter relatedproblems can even cause a temporary or permanent transfer tohemodialysis (“HD”) for many patients. The incidence of peritonitis,another major problem with PD, is declining due to the introduction ofnew connectology, which highlights further the need to address catheterrelated complications.

The success of PD catheter implantation depends upon the degree ofavoidance of various problems such as: inflow/outflow failure, leakage,abdominal wall-related hernias and catheter infection. Leakage isrelated to the catheter implantation technique, trauma, and/oranatomical abnormalities of the patient. Leakage can occur early (e.g.,less than thirty days after implantation), or late (e.g., greater thanthirty days), following the start of PD, and can be external orsubcutaneous.

Early leakage is usually external, appearing as fluid through the woundor the exit site. Subcutaneous leakage can develop at the site of theincision or at the entry into the peritoneal cavity soon after catheterimplantation and after PD commences. Leakage at the exit site or throughthe wound increases the risk of peritonitis. The cause of late leakageis often difficult to diagnose.

One solution for alleviating the problems caused by leakage is allowingthe catheter insertion wounds to heal before beginning PD therapy.Certain techniques for burying PD catheters, such as the StepwiseMoncrief and Popovich (“SMAP”) technique, require a period of time topass after the catheter resides completely subcutaneously in the patientbefore PD treatments begin.

Inflow/outflow obstructions occur frequently and can have variouscauses, such as: (i) mechanical obstruction (tip migration, kinks,etc.); (ii) constipation; and (iii) catheter blockage. Outflowobstructions (typically one-way obstructions) are the most frequentobstructions, causing poor flow and failure to drain the peritonealcavity. Outflow obstructions can be caused by factors present inside thecatheter, such as from debris due to a blood clot or fibrin, or fromfactors present outside the catheter, such as bowel enwrapping thecatheter (constipation), occlusion of the catheter holes, catheter tipdislocation or tip entrapment in peritoneal pockets.

Inflow obstructions are caused by the kinking of the catheter, forexample in the subcutaneous tunnel, or again from debris existing insidethe catheter such as clots or fibrin. Techniques for removingobstructions range from noninvasive approaches, such as: (i) bodyposition changes and laxatives, (ii) pushing or sucking with aheparinized saline, (iii) infusing fibrinolytic agents (e.g., urokinase,streptokinase) into the catheter for a number of hours; or (iv) heparinin doses. Techniques for removing obstructions also include moreaggressive techniques, such as: (i) fluoroscopically guiding a styletthrough the catheter; (ii) cleaning the catheter with an intraluminalbrush or other utensil; or (iii) using peritonescopy to visually corrector replace the catheter.

Leaving the catheter in the patient's body for a period of time beforebeginning PD therapy decreases the likelihood of leakage but increasesthe likelihood that fibrin, waste, proteins or other materials willenter the catheter and form a block. A need exists for an apparatus andmethod that allow the catheter to reside inside the patient for anextended period of time and to prevent the catheter during this timefrom becoming partially or completely blocked.

SUMMARY OF THE INVENTION

The present invention includes an improved dialysis catheter and methodof inserting same. One insertion technique useful with the catheter ofthe present invention, the SMAP technique, is becoming increasinglypopular. The SMAP technique allows various types of PD catheters to beimplanted into the peritoneal cavity in the usual manner. Afterward, anexternal portion of the catheter is buried temporarily under the skin.Fifteen centimeters typically of the catheter is directed back throughthe exit site and under the skin where it remains for a period of time,such as one to six months. With this technique, PD catheters areimplanted in advance of the need for their use. The technique reducesleakage by allowing leak points to heal after implantation and alsoallows a fibrous ingrowth to the catheter cuffs (the cuffs are tubularmounting structures that fix the inserted connector within the patient)to be completed.

While the catheter set and method of implanting same are described inconnection with the SMAP method, the catheter of the present inventionmay have various configurations as described below, may be used withvarious installation techniques and may be used with various differenttypes of dialysis, such as PD and CAPD. The catheter includes an insert,otherwise termed herein as an obstructor. The obstructor fills themajority of the inside annular space within the catheter. The obstructoris generally tubular in an embodiment and has an open extraperitonealend and either an open or closed intraperitoneal end.

Only a small space is left between the catheter and the insect, which isfilled with saline, such as heparinized saline. The insert and salineprevent fibrin, proteins and other material from collecting inside thecatheter, which is especially helpful in the SMAP method where thecatheter is left inside the patient for months before PD therapy begins.

To insert the catheter and obstructor, the obstructor is fitted with astylet, which is stiff relative to the catheter and insert and allowsthe doctor to position properly the catheter into the peritoneal cavity.The stylet also has a ring or grasping portion extending out of theinsert that allows the stylet to be grasped easily. After the doctor hasplaced the catheter into the patent, the doctor removes the stylet,leaving the catheter.

The intraperitoneal end of the catheter defines a number of aperturesthat allow dialysate to flow into and out of the catheter from variousplaces inside the peritoneal cavities. The insert or obstructor likewisedefines a series of holes, e.g., one to thirty holes. The insect holesare located closer to inlet of the catheter and insert than are thecatheter holes, e.g., near the cuffs of the catheter. The insert holesare located alternatively on one side or the other from the center ofthe insert. After the stylet is removed, the doctor secures the innercuff to the peritoneal membrane and ensures that the catheter isunobstructed by injecting saline via a syringe. The saline fills theannular cavity of the obstructor. A portion of the saline exists theinsert holes and fills the small space between the obstructor and thecatheter.

The SMAP method involves the creation of a “swan-neck” type turn withthe extraperitoneal portion of the catheter, which requires additionalincisions to be made in the patient. To make these incisions, the doctoruses a subcutaneous cutting device known as a trocar. The trocar fitsinto the extraperitoneal end of the catheter or insert and guides thecatheter using the trocar.

After the cuffs are in place and the extraperitoneal portion of thecatheter is inserted for its temporary stay inside the patient, thedoctor injects heparinized saline into the insert and places a plug inthe extraperitoneal end of the obstructor to hold the saline in placeand to close the open end of the peritoneal cavity. One or more piecesof surgical string may be necessary lo tighten the catheter/insert/plugassembly. The method of the present invention may be performedalternatively without (he use of surgical string.

The doctor staples and/or sows together the implantation incisions withthe catheter buried completely subcutaneously. After the waiting periodof four weeks to six months, the doctor makes a different incision toretrieve the external portion. The doctor locates the catheter end bytouch typically, however, the insert and plug each contain a radioopaque strip so that the location of the catheter/obstructor can befound by x-ray if needed.

Upon retrieving the external portion of the catheter, the doctor removesthe plug and again injects saline into the insert. The saline fills theannular space of the insert and flows out of the insert apertures intothe small space between the insert and the catheter. In this manner thesaline acts as a lubricant for removing the insert from the catheter.The insert is removed easily. The external end of the catheter issecured to the outside of the patient, who is then ready to receive PDtreatment.

It is therefore an advantage of the present invention to provide acatheter set for use with dialysis.

It is another advantage of the present invention to provide a catheterset for use with different types of catheters.

It is a further advantage of the present invention to provide a catheterset for use with different types of catheter implantation procedures.

Moreover, it is an advantage of the present invention to provide acatheter set for use with different types of peritoneal dialysisprocedures.

It is still further an advantage of the present invention to provide acatheter set for use with the SMAP insertion method.

It is still another advantage of the present invention to provide acatheter set for dialysis that dissuades fibrin and other contaminantsfrom entering the catheter.

Additional features and advantages of the present invention aredescribed in, and will be apparent from, the following DetailedDescription of the Invention and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic perspective view of the various devices of thecatheter set of the present invention.

FIGS. 2 to 4 illustrate schematically different configurations for theintraperitoneal portion of the catheter of the present invention.

FIGS. 5 to 13 illustrate schematically different configurations for theextraperitoneal portion of the catheter of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention includes a dialysis catheter, a medical setincluding the catheter and a method of installing same. A number ofcatheter related complications are associated with PD, includingdialysate leak, fibrin plug, outflow obstruction, cuff extrusion,herniation, exit-site or tunnel infection, and peritonitis. Several ofthese complications may necessitate catheter repositioning andoccasionally replacement. Efforts to reduce the catheter-relatedcomplications associated with PD have focused on improved connectiontechnology, new implantation techniques and innovative catheter designs.

One approach to reduce leakage has been to delay use of the peritonealcatheter. after insertion to permit complete healing of the subcutaneoustunnel. This method helps to avoid several factors that predispose tothe development of exit-site infections, including peritoneal dialysateleaks and excessive pulling and twisting of the catheter duringexchanges. One risk associated with delayed initiation of PD followingcatheter placement is the increased likelihood that the installedcatheter will become partially or fully blocked within material, such asfibrin, waste, proteins and other toxins. The purpose of the presentinvention is to enable the catheter to reside inside the patient for adesired period of time, such as one to six months, before PD therapybegins and at the same time prevent the catheter from becoming blockedor obstructed as well as to make catheter implantation easier.

Referring now to the drawings and in particular to FIG. 1, a catheterset 100 is illustrated. The set includes a catheter 10. Catheter 10includes an intraperitoneal portion 12 and an extraperitoneal portion14. The extraperitoneal portion 14 includes a subcutaneous part 16 andan external part 18 that resides eventually outside the patient's body,i.e., beyond the exit site.

The subcutaneous part 16 of the extraperitoneal portion 14 of thecatheter 10 includes at least one cuff 20. The cuffs 20 enable thecatheter to be structure or anchored inside the patient's body. FIG. 1is illustrated with a two-cuff, straight Tenckhoff type catheter 10,which is used widely because it satisfies the needs of many patients.Many catheter variations exist, which are designed to minimizecomplications of pain, inadequate flow and infection. The presentinvention expressly includes each of these variations, some of which areillustrated in FIGS. 2 to 13.

FIGS. 2 to 4 illustrate variations for (he intraperitoneal portion 12 ofthe catheter 10. Besides the straight intraperitoneal portion 12illustrated above in FIG. 1, portion 112 can be coiled as illustrated inFIG. 2. The coiled portion 112 can be used with most of theextraperitoneal configurations in FIGS. 5 to 13. The coiledconfiguration 112 provides an increased bulk of tubing and more sideholes (not illustrated) for outflow.

Portion 212 of FIG. 3 includes silicone or polymer disks 210. Siliconediscs 210 extend perpendicular to the catheter portion 212 and hold thebowels away from the exit holes (not illustrated). Disks 210 also helpto minimize catheter tip migration. Portion 312 of FIG. 4 is known as a“T-Flute” catheter. Instead of side holes, portion 312 defines aplurality of thin, longitudinal “flutes” or grooves 310.

Referring now to FIGS. 5 to 13 variations of the subcutaneous parts ofthe extraperitoneal portion of the catheter of the present invention areillustrated. FIG. 5 illustrates subcutaneous part 16 of portion 14 ofFIG. 1 in more detail. The SMAP part 16 includes a swan-neck asillustrated. The external skin cuff 20 is elongated to about 2.5centimeters and is tapered at the ends.

FIGS. 6 to 9 illustrate straight variations. FIGS. 6 and 7 illustratestraight subcutaneous parts 116 and 216 with single and double cuffs 20,respectively. FIGS. 8 and 9 illustrate straight configurations 316 and416 with single and double cuffs 20, respectively, wherein the deep cuff20 has a bead and/or flange. The bead and flange strengthen theanchorage of the catheter to the abdominal wall, which increases themass of tissue in growth into the cuff/flange structure, decreasing therisk of leakage. The bead and flange can be affixed to the tubing at aforty-five degree angle to orient the intraperitoneal portion 12properly.

The single cuff subcutaneous parts 116 and 316 have been known to havemore exit site complications and shorter survival times than thedouble-cuff subcutaneous parts 216 and 416, rendering the double cufftype catheters preferable in an embodiment. The cuffs 20 are made ofpolyester fiber in an embodiment. The distance between two cuffs 20 isabout five centimeters in an embodiment.

FIGS. 10 to 13 illustrate various types of swan-neck subcutaneous parts.Swan-necks lessen the occurrence of cuff extensions and catheter tipmigration associate with straight catheters. The 90 to 180 degree bendallows the catheter to exit the skin pointing downward and yet enter theperitoneum pointing toward the pelvis, in an unstressed condition.

FIGS. 10 and 11 illustrate subcutaneous parts 516 and 616 with performedbends, eliminating the resilience force or “shape memory” of straightcatheters. One of the cuffs 20 of subcutaneous part 616 includes a beadand flange. FIG. 12 illustrates a swan-neck subcutaneous part 716, whichhas a subcutaneous tunnel of extended length. Subcutaneous part 716includes two silicone rubber tubes 718 and 720 that are connected at thetime of implantation. The implanted lower tube 718 forms theintraperitoneal portion 12 and has one cuff 20 with a bead and flange.The upper tube 720 has two cuffs 20, one on either side of the bentsegment. FIG. 13 illustrates a swan-neck subcutaneous part 816, whichhas two right angle bends, one to direct the intraperitoneal portion 12parallel to the peritoneal peritoneum, and one to direct thesubcutaneous portion 14 downward toward the skin exit site.

Each of the catheters and portion is illustrated in FIGS. 1 to 13 can bemade of one or more of a plurality of materials. One common material issmooth silicone rubber. Silicone is biocompatible because it is inert,soft, flexible, and contains no known harmful plasticizers. Anothersuitable catheter material is polyurethane. Polyurethane provides morewall strength than silicone, allowing for thinner walled catheters withlarger lumens. Other suitable materials include teflon, polypropylene aswell as other biocompatible materials.

Referring again to FIG. 1, the catheter set 100 includes an insert orobstructor 30, which is fitted into any of the intraperitoneal portionsor subcutaneous parts described above in connection with FIGS. 2 to 13,as well as the portions 12 and 14 illustrated in FIG. 1. For purposes ofdescribing the present invention, insert and obstructor mean the same.Insert 30 includes an elongated tubular portion 32 having an openextraperitoneal end 34 and an open or closed intraperitoneal end 36 (end36 of portion 32 shown in solid as being closed and in phantom asalternatively being open).

Extraperitoneal end 34 includes a larger diameter portion 38. Largerdiameter portion 38 in an embodiment is a section of tube that fitssnugly over the outer diameter of the elongated tubular portion 32,wherein larger diameter portion 38 is adhered with a medically safesealant, heat scaled, ultrasonically welded or otherwise connectedpermanently to the elongated tube portion 32 in such a manner that themethod of attachment is safe physiologically to contact internal bodilyfluids.

Obstructor 30 can be made from one or more materials. Materials suitablefor use with the insert or obstructor include silicone, teflon (hard orsoft), polyethlene, polyurethane, any other type of biocompatibleplastic and any combination of these. In an embodiment, the insertincludes a metal frame, such as a metal mesh or metal spiral, toreinforce the strength of the insert and to make the insert more rigid.The metal used to reinforce the insert is biocompatible, such asstainless steel or titanium.

When catheter 10 is inserted into the patient, the insert 30 residesinside catheter 10 so that intraperitoneal end 36 of insert 30, which isalternatively open or closed, is at or extending past the end 24 of thecatheter 10 at the intraperitoneal portion. The larger diameter portion38 of the extraperitoneal end 34 of insert 30 wedges into, i.e.,pressure fits inside end 22 of catheter 10 at the external part 18 oftie extraperitoneal portion 14. Catheter end 22 may be secured to: (i)the larger diameter portion 38, (ii) the elongated tube portion 32directly adjacent to the larger diameter portion 38, and/or (iii) theintraperitoneal end 36, respectively, via one or more pieces of surgicalstring 26.

In an alternative embodiment, larger diameter portion 38 of theextraperitoneal end 34 of insert 30 abuts end 22 of catheter 10 ratherthan press fitting into end 22. In this instance, the outside diameterof larger diameter portion 38 is the same as, i.e., flush with theoutside diameter of catheter 10. A third, larger tube section (notillustrated) is then slid over the interface between larger diameterportion 38 and catheter 10. The third tube section is adhered ontoportion 38 and catheter 10 via a medically safe sealant or via methoddiscussed above in connection with the connection of portion 38. Afterretrieving the external part 18 of catheter 10, the doctor removesinsert 30 by cutting away the third tube with scissors.

The catheter 10 and insert or obstructor 30 are sized so that theelongated tube portion 32 fits very snugly inside catheter 10. In anembodiment, the inner diameter of catheter 10 is about 3 millimeters,while the outside diameter of the elongated tube portion 32 is about 2.8millimeters. About one tenth of a millimeter resides therefore betweenthe outer surface of the elongated portion 32 and the inner surface ofcatheter 10. The larger diameter portion 38 has a diameter of greaterthan 3 mm, which allows portion 38 to stretch the polymer catheter 10 tomake a tight press fit.

The catheter 10 and insert 30 are glided by a doctor collectively usinga guide or stylet 50, which is inserted initially into insert 30. Thestylet 50 includes a thin rod portion 52. A ring portion or handle 54 isformed at one end of rod portion 52 of stylet 50. The end 56 of stylet50 is inserted into insert 30 so that end 56 extends all the way to theend 36 of insert 30. Ring 54 resides just outside of the larger diameterportion 38 of insert 30. The guide or stylet 50 is a biocompatible metalin an embodiment, such as stainless steel or titanium.

Stylet 50 enables the doctor to grab and grasp ring 54 and providesenough rigidity in combination with the insert 30 and catheter 10 toguide the intraperitoneal portion 12 deep into the patient's peritonealcavity. The doctor guides end 56, intraperitoneal end 36 of insert 30,which is open or closed, and end 24 of catheter 10 collectively so thatat least a portion of the apertures 28 of catheter 10 reside along thebottom of the patient's peritoneal cavity.

After the catheter 10, insert 30 and stylet 50 have been inserted intothe proper position within the patient, the doctor removes stylet 50.Depending on the type of extraperitoneal design of the catheter, thereexists a length of the catheter, namely, the subcutaneous part 16 andexternal part 18 that remain outside the patient's body even after thecatheter assembly is inserted into the peritoneal cavity. The doctorholds a section of the portion residing outside the patient's body andremoves easily the guide or stylet 50 from inside of the insert 30. Thelarger diameter portion holds insert 30 snugly within the catheter 10,despite any shearing force created while the stylet 50 is being removedfrom the elongated tube portion 32 of the insert 30. The catheter 10 andthe obstructor 30 remain in the proper implanted position within theperitoneal cavity during and after the removal of the guide or stylet 50from insert 30.

After removal of stylet 50, a trocar 60 is secured to theextraperitoneal end 34 of the insert 30. Trocar 60 is a cuttinginstrument made of a biocompatibly safe metal, such as stainless steelor titanium. Trocar 60 includes attachment end 62 and a blade end 64.Attachment end 62 is inserted into either the larger diameter portion 38or the elongated tube portion 32 of insert 30, wherein surgical string26 is tied about portion 38 or the catheter 10 to secure catheter 10 andinsert 30 to trocar 60.

As is well known in the art, the doctor uses the trocar 60, whichincludes an extended handle 66, to insert blade 64 into the originalincision made in the patient and cut a second incision in the patientfrom underneath the skin, i.e., subcutaneously. The doctor then installsthe extraperitoneal portion 14 of catheter 10 according to the desiredimplementation. As discussed above, in one preferred embodiment, the set100 is used for the SMAP method of implantation. With SMAP, or anyprocedure requiring a swan-neck type of bend, the doctor reinserts thetrocar through the second incision, cuts a thin incision subcutaneouslyusing the trocar 60, bends and moves the catheter inside the patient andthen removes the trocar from the extraperitoneal end 34 of insert 30 andlikewise from catheter 10.

The doctor then uses a syringe 70 to inject a heparinized saline intothe end 34 and cavity defined by insert 30. The syringe 70 includes aninjection end 72 that fits either inside of the larger diameter portion38 or inside of the elongated tube portion 32 of the insert 30. Theinjected the heparinized saline performs two functions. First, thesaline fills the inner cavity defined by the elongated tube portion 32of insert 30 with liquid, further preventing fibrin, proteins, etc. fromentering the insert 30, e.g., through apertures 40. Second, the smallvolume residing between the outer surface of the elongated portion 32and the inner surface of the catheter 10 is filled with the heparinizedsaline via the apertures 40 defined by elongated portion 32. Theheparinized saline helps to keep fibrin and proteins, etc., fromentering the catheter 10 through apertures 28 or end 24.

Insert 30 of set 100 does not have to define apertures 40. In onepreferred embodiment, however, at least one and as many as thirtyapertures 40 are defined by elongated tube portion 32. Apertures 40, aswith apertures 28 in catheter 10, may reside on opposite sides of theelongated portion 32, for example, as pairs, or be one more very thinflutes. The apertures 40 in one preferred embodiment are located at adifferent portion of the length of insert 30 than are apertures 28 alonga corresponding length of catheter 10. For example, as illustrated, theapertures 28 of catheter 10 are located closer to end 24 of catheter 10,while apertures 40 in the elongated tube portion 32 are located closerto the extraperitoneal end 34, e.g., corresponding to approximately thecuff 20 closest to end 22 of catheter 10.

For SMAP as well as other types of PD, the subcutaneous part 16 makes aswan-neck 90 to 180 degree bend, so that end 22 of catheter 10 andextraperitoneal end 34 of insert 30 point upwards toward the patient'shead. The second incision enables the doctor to bend the catheter/insertto make the desired “U” turn. The third incision enables the doctor toremove the end 22 of catheter 10 and extraperitoneal end 34 of insert 30to: (i) remove the trocar from the larger portion 38 or end 34 of insert30; (ii) insert saline via syringe 70 as described above; and (iii)insert a plug 80 into larger diameter 38 or elongated portion 32 to holdthe saline with insert 30.

Plug 80 in an embodiment includes a larger diameter section 82 that fitssnugly into larger diameter portion 38 and a smaller diameter portion 84that fits snugly into elongated portion 32. The larger diameter section82 can extend out from larger diameter portion 38 or include a head thatenables the doctor to grasp and remove plug 80 after it has beeninserted into obstructor 30. One or more pieces of surgical string 26can be used about catheter 10 or portion 38 to tighten and help sealplug 80. Plug 80 and insert 30 each include a radio opaque strip 86 thatenables insert 30 to appear on an x-ray.

Once implanted, the doctor sows or staples closed the three incisions.Thereafter, the doctor should be able to locate external part 18 bytouch. Radio opaque strip 86 is safeguard against movement ofextraperitoneal portion 14 and part 18 or in cases of extreme obesity.

For SMAP, the catheter is left inside the patient for a period of time,such as four weeks to six months during which PD therapy is notperformed. This dwell time allows tissue to grow around the cuffs andthe implantation wounds to heal, decreasing the risk of leakage. Afterthis period of time, the doctor removes the external part 18 of theextraperitoneal portion 14 of the catheter 10 from the body so that thecatheter can be used for therapy. The doctor determines an exit site forthe external part 18, which is usually either above or below but not onthe belt line, not on a scar (i.e., at any of the locations forinserting the catheter 10) and not in abdominal folds.

Once the doctor has located and removed the external part 18 of catheter10, the doctor removes plug 80 from insert 30. To remove insert 30, thedoctor again injects saline via syringe 70 into the end 34 of the insert30. The injected saline again performs dual functions. First, the salinefills the inner cavity defined by the elongated tube portion 32 ofinsert 30 with liquid and, trough apertures 40, fills the small volumeresiding between the outer surface of the elongated portion 32 and theinner surface of the catheter 10 with the saline. The saline flushesbuilt up fibrin and proteins from catheter 10 through apertures 28 andend 24. Second, the saline acts as a lubricant so that insert 30 isthereafter removed easily from catheter 10.

Once insert 30 is removed, the doctor can flush the open catheter withsaline. The external part 18 is then secured so that a portion thereofextends outside the body, allowing the patient to begin PD therapy. Theinsert, taking up much of the lumen of catheter 10 reduces the amount offibrin and other materials described above from collecting insidecatheter 10, increasing the likelihood that the implantation of catheter10 is successful.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present invention andwithout diminishing its intended advantages. It is therefore intendedthat such changes and modifications be covered by the appended claims.

1. A catheter set for peritoneal dialysis comprising: a catheter havingfirst and second ends; and an insert filling a majority of an interiorspace defined by the catheter, the insert defining a cavity and havingan extraperitoneal end and an intraperitoneal end.
 2. The set of claim1, which includes a plug placed in the extraperitoneal end of the insertafter the catheter and insert have been implanted in a patient.
 3. Theset of claim 1, wherein the intraperitoneal end of the insert is open orclosed.
 4. The set of claim 1, wherein the catheter and insert arepackaged together.
 5. The set of claim 1, which includes a guide placedin the cavity of the insert before the catheter and insert have beenimplanted in the patient.
 6. The set of claim 1, wherein at least one ofthe insert and the plug includes a radio opaque member.
 7. The set ofclaim 1, wherein the insert is metal reinforced.
 8. The set of claim 1,wherein the catheter is a tube and insert fills most of an open spacedefined by the tube.
 9. The set of claim 1, which includes a syringe forinjecting a liquid into the cavity.
 10. The set of claim 9, wherein theliquid is saline.
 11. The set of claim 1, wherein at least one of thecatheter and the insert includes a tubular wall that defines at leastone aperture.
 12. The set of claim 11, wherein the apertures are locatedat a different section of the tubular wall of the catheter than are theapertures in the tubular wall of the insert.
 13. The set of claim 11,wherein at least one aperture is an elongated flute.
 14. The set ofclaim 1, wherein the insert is at least as long as the catheter.
 15. Theset of claim 1, which includes at least one piece of surgical stringsecuring the catheter and the insert.
 16. A catheter set for peritonealdialysis comprising: a catheter leaving first and second open ends; aninsert placed inside the catheter, the insert defining a cavity andhaving an extraperitoneal end and an intraperitoneal end; and a guideplaced in the cavity and extending from the extraperitoneal end of theinsert.
 17. The catheter set of claim 16, wherein the guide is metal.18. The catheter set of claim 16, which includes a trocar secured to theextraperitoneal end of the insert when the guide has been removed. 19.The catheter set of claim 16, wherein the guide defines a portionconfigured and arranged to be grasped and moved by a person.
 20. Thecatheter set of claim 16, wherein the catheter includes at least onecuff.
 21. The catheter set of claim 20, wherein the cuff includes atleast one of a bend and a flange.
 22. The catheter set or claim 16,wherein a portion of the catheter and insert is coiled.
 23. Anobstructor for occupying space within a tubular catheter when insertedinto a catheter, the catheter defining first and second ends, theobstructor comprising: a tube including an extraperitoneal end and anintraperitoneal end, the extraperitoneal end including a portion havingan increased diameter, the portion contacting the first end of thecatheter when the tube is inserted into the catheter, theintraperitoneal end of the tube extending at least substantially to thesecond end of the catheter, an outer diameter of the tube fittingsubstantially an interior space defined by the tubular catheter.
 24. Theobstructor of claim 23, wherein the larger diameter portion is sized topress-fit inside the catheter.
 25. The obstructor of claim 23, whereinthe tube houses a radio opaque member.
 26. The obstructor of claim 23,wherein the tube is a first tube and the larger diameter portion is asecond tube adhered to the first tube.
 27. The obstructor of claim 23,wherein the tube is made from at least one material selected from thegroup consisting of silicone, teflon, polyurethane, polypropylene, metalmesh, metal spiral, and an combination thereof.
 28. The obstructor ofclaim 23, wherein the tube defines at least one aperture along itslength that allows fluid injected into the extraperitoneal end to exitthe tube.
 29. The obstructor of claim 23, which includes a plug insertedinto the extraperitoneal end.
 30. The obstructor of claim 29, whereinthe plug is made from at least one material selected from the groupconsisting of: silicone, teflon, polyurethane, polypropylene, metal andany combination thereof.
 31. A method for inserting a cathetercomprising the steps of: making an incision into a patient; insertingthe catheter, the catheter having an insert filling most of the internalspace defined by the catheter; and removing the insert after thecatheter has been implanted.
 32. The method of claim 31, wherein a guideis placed initially into the insert; and which includes the steps ofusing the guide to maneuver the catheter inside the patient and thenremoving the guide.
 33. The method of claim 31, wherein the insertincludes a tubular length and at least one hole defined by the tubularlength, and which includes the step of injecting fluid into the tubularlength, through the hole between the insert and the catheter.
 34. Themethod of claim 33, which includes the step of placing a plug in theinsert after injecting the fluid into the insert.
 35. The method ofclaim 33, which includes the step of removing the insert after injectingthe fluid.
 36. The method of claim 31, wherein at least one cuff ispositioned on the catheter, and which includes the step of securing thecuff to the patient.
 37. The method of claim 31, which includes making aplurality of incisions into the patient and the step of using themultiple incisions to guide the catheter in a plurality of directions.38. The method of claim 37, which includes the step of using aninstrument to bend the catheter inside the patient.
 39. The method ofclaim 31, which includes the step before removing the insert of closingthe insertion with the catheter and insert implanted inside the patient.40. The method of claim 31, wherein removing the insert occurs after aperiod of time in which the insert and catheter have resided inside thepatient.
 41. The method of claim 31, which includes the step of flushingthe catheter after the insert has been removed.
 42. The method of claim31, which includes the step of securing one end of the catheter toreside outside the body of the patient after the insert has beenremoved.
 43. The method of claim 31, wherein the catheter is preformedto have a bend, wherein inserting the catheter includes inserting thepreformed catheter.
 44. A method of implanting a catheter comprising thesteps of: implanting the catheter inside a patient, the catheter havingan obstruction tending to disallow material from entering the catheter;leaving the entire catheter inside the patient for a period of time; andremoving the obstruction and securing a portion of the catheter toextend outside the patent.